Claims for Patent: 11,564,933

Summary for Patent: 11,564,933

Title:	Methods of treating testosterone deficiency
Abstract:	Methods of treating a testosterone deficiency or its symptoms with a pharmaceutical formulation of testosterone esters are provided. In some embodiments, the subject has adequately controlled blood pressure.
Inventor(s):	Robert E. Dudley, Theodore Danoff
Assignee:	Tolmar Inc
Application Number:	US16/382,835
Patent Claims:	1. A method of treating conditions associated with a deficiency or absence of endogenous testosterone in a subject in need thereof who has adequately controlled blood pressure, said method comprising: administering twice daily to the subject a defined dose of an oral pharmaceutical composition comprising about 15-20 percent by weight of solubilized testosterone undecanoate, about 5-20 percent by weight of hydrophilic surfactant, about 50-70 percent by weight of lipophilic surfactant which is a fatty acid; and about 10-15 percent by weight of digestible oil, wherein said oral pharmaceutical composition exhibits a percent (%) in vitro dissolution profile in 5% TRITON X-100 (Polyethylene glycol tert-octylphenyl ether) solution in phosphate buffer, pH 6.8, indicating release from the composition of substantially all of the solubilized testosterone undecanoate within about 2 hours. 2. The method of claim 1, wherein the subject is not being treated with antihypertensive therapy. 3. The method of claim 1, wherein the subject is being treated with antihypertensive therapy. 4. The method of claim 1, wherein the subject does not have a history of hypertension. 5. The method of claim 1, wherein the subject has a history of hypertension. 6. The method of claim 1, further comprising: administering twice daily for approximately three weeks to the subject the defined dose of the oral pharmaceutical composition; monitoring the subject for new-onset hypertension or exacerbation of pre-existing hypertension; and treating the subject for new-onset hypertension or exacerbation of pre-existing hypertension. 7. The method of claim 1, further comprising: administering twice daily to the subject an increased dose of the oral pharmaceutical composition; monitoring the subject for new-onset hypertension or exacerbation of pre-existing hypertension; and treating the subject for new-onset hypertension or exacerbation of pre-existing hypertension. 8. The method of claim 1, wherein the subject is diagnosed with hypogonadal conditions associated with structural or genetic etiologies. 9. The method of claim 1, wherein the subject is diagnosed with primary hypogonadism. 10. The method of claim 9, wherein the subject is diagnosed with testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. 11. The method of claim 1, wherein the subject is diagnosed with hypogonadotropic hypogonadism. 12. The method of claim 11, wherein the subject is diagnosed with gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. 13. The method of claim 1, wherein the subject is not diagnosed with age-related hypogonadism. 14. The method of claim 1, further comprising informing the subject that administration of the oral pharmaceutical composition may result in an increase in blood pressure. 15. The method of claim 14, wherein administration of the oral pharmaceutical composition results in an average increase of systolic blood pressure of 4.9 mm Hg based on ambulatory blood pressure monitoring. 16. The method of claim 14, wherein administration of the oral pharmaceutical composition results in an average increase of systolic blood pressure of 2.8 mm Hg based on blood pressure cuff measurements. 17. The method of claim 1, further comprising informing the subject that co-administration of the oral pharmaceutical composition with a prescription medication known to increase blood pressure and/or a nonprescription analgesic and/or a cold medication may result in additional increases in blood pressure. 18. The method of claim 1, further comprising monitoring the subject's blood pressure. 19. The method of claim 1, further comprising informing the subject that administration of the oral pharmaceutical composition may result in an increased risk of a major adverse cardiovascular event (MACE). 20. The method of claim 1, wherein the MACE is chosen from myocardial infarction, stroke and cardiovascular death. 21. The method of claim 16, wherein the subject has one or more cardiovascular risk factors or established cardiovascular disease. 22. The method of claim 1, further comprising: collecting said subject's blood sample; measuring the serum testosterone concentration in the subject; and if the measured serum testosterone concentration is less than about 425 ng/dL, increasing the dose of testosterone undecanoate administered; if the measured serum testosterone concentration is greater than about 970 ng/dL decreasing the dose of testosterone undecanoate; and if the measured serum testosterone concentration is between about 425 ng/dL and about 970 ng/dL, maintaining the dose of testosterone undecanoate administered. 23. The method of claim 1, wherein the defined dose comprises about 237 mg of testosterone undecanoate. 24. The method of claim 23, wherein the dose of testosterone undecanoate is increased by about 40 mg to about 80 mg when the measured serum testosterone concentration in the subject is less than about 425 ng/dL. 25. The method of claim 23, wherein the dose of testosterone undecanoate is decreased by about 10 mg to about 40 mg when the measured serum testosterone concentration in the subject is greater than about 970 ng/dL. 26. The method of claim 22, wherein the serum testosterone concentration is measured four to eight hours after administering the oral pharmaceutical composition. 27. The method of claim 1, wherein said oral pharmaceutical composition exhibits a percent (%) in vitro dissolution profile in 5% Triton X-100 solution in phosphate buffer, pH 6.8, indicating release from the composition of substantially all of the solubilized testosterone undecanoate within about 1 hour.